TORONTO – Novel. Unique. Revolutionary. Terms too often used to indiscriminately describe medical devices that have yet to prove their stuff. Not so at France’s Ministry of Health which takes care to deem winning devices under its Forfait Innovation (FI) program “truly innovative, not simply incremental developments.” Last week the FI awarded Vancouver, British Columbia’s Evasc Neurovascular Inc. €2.76 million (US$3.37 million) to test its CE-marked Eclips for treating intracranial bifurcation aneurysms during a 119-patient trial at 20 French sites in 2021.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Biotechnologies, Cochlear, Ortho Clinical Diagnostics, Promaxo, Siemens Healthineers.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Endosurgery, Avacta, Gallup, Dentsply Sirona, Hancock Jaffe, Hologic, Ion Beam Applications, Mainstay Medical, Motus GI, Ndc, North American Dental Group, North Star Medical Radioisotopes, Oxford Immunotec Global.
Keeping you up to date on recent developments in cardiology, including: TAVR patients at low surgical risk still ahead vs. SAVR, but thrombosis a concern; Heart failure numbers nearly doubled between 1990 and 2017; COVID exerting large effect on heart health.
The FDA issued an advisory about the use of thermal imaging systems as screening instruments for the COVID-19 pandemic landing the same day as a warning letter to Certify Global Inc. The agency’s concern is that these systems are being used without consideration for the limitations, including that they are not appropriate for mass screenings due to inaccurate findings that could elevate the risk of spread of the SARS-CoV-2 virus.
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